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GB/T 21607-2022: Chemicals - Test method of one-generation reproduction toxicity
Status: Valid GB/T 21607: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21607-2022 | English | 159 |
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Chemicals - Test method of one-generation reproduction toxicity
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GB/T 21607-2022
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| GB/T 21607-2008 | English | 239 |
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Chemicals -- Test method of one-generation reproduction toxicity
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GB/T 21607-2008
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PDF similar to GB/T 21607-2022
Standard similar to GB/T 21607-2022 GB/T 21617 GB 23350 GB/T 21622 GB/T 21604 Basic data | Standard ID | GB/T 21607-2022 (GB/T21607-2022) | | Description (Translated English) | Chemicals - Test method of one-generation reproduction toxicity | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Word Count Estimation | 7,753 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 21607-2008: Chemicals -- Test method of one-generation reproduction toxicity---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Chemicals. Test method of one-generation reproduction toxicity
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemical generation reproductive toxicity testing
Posted 2008-04-01
2008-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This revised standard adopts the United Nations Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method No. 415 "generation reproductive toxicity RESEARCH
Study "(1983).
This standard OECD Chemicals Test Method No. 415 compared with the following differences.
--- To OECD Chemicals Test Method No. 415 were editorial changes;
--- Increased the preamble;
--- Standard text format press on GB/T 1.1-2000 made editorial changes.
This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points.
This standard is drafted by. Tianjin Inspection and Quarantine Institute of Science and Technology.
Participated in the drafting of this standard. Jiangnan University, China Chemical standardization, Tianjin Exit Inspection and Quarantine, China Disease Prevention and Control
Heart of Occupational Health and Poison Control.
The main drafters. Zhang Yuan, Wangli Bing, Li Xue Yang, Zhao Zhuo, Wang Xiaobing, Xu came, Li Chaoyang.
This standard was first formulated.
Chemical generation reproductive toxicity testing
1 Scope
This standard specifies the chemical generation reproductive toxicity studies in experimental animals, the test procedure, the results of the evaluation and test report.
This standard is applicable to the detection of chemical generation reproductive toxicity.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 14924.1 animal feed common quality standards
GB 14925 Laboratory Animal Facilities and Environment
3 Terms and Definitions
3.1
Refers to the damage caused by chemicals is reduced female or male reproductive function or fertility, such as the decline in reproductive rates; or cause progeny
Non-hereditary adverse effects, such as growth and developmental toxicity, including teratogenic effects of damage to health and the breast-feeding period.
4 test animals
4.1 species and strain selection
First choice for healthy adult rats or mice. The most commonly used weaning, 7 to 8 weeks old, at least through 5d adaptation of animals for breeding
Toxicity test. Female animals must not have been produced Aberdeen.
4.2 the number of animals
Males and females usually in a ratio of 1 or 1.2 mated. The number of animals mating should ensure that each dose group and control group
Access to about 20 pregnant rats.
4.3 rearing environment
Experimental animal husbandry and environmental facilities shall comply with the provisions of GB 14925 and GB 14924.1. The test animals using free diet.
When pregnant rats approaching childbirth, childbirth should be caged in a cage, the cage in place when needed build nest litter.
5 test procedure
5.1 and control group
Before the exposure dose animals were randomly divided into two groups. If the test sample using a vehicle control group should be used excipients
Maximum use level parallel exposure. If the test sample cause a decline in animal food intake and utilization, then the control animals
Paired with experimental animals need feeding.
5.2 dose levels
The experiment included at least three dose groups and a control group. The highest dose should enable the parent animals significant toxicity, but does not cause movement
Was dead; intermediate doses can cause mild toxicity; low dose should not induce any toxic effects in animals and their offspring. If that sample
Less toxic products, the dose of 1000mg/kg, the reproductive process has not produced any toxic effects, you can use a limited test, that test
Test does not need to set up additional dose group. If the pre-test to the effect of high doses of significant maternal toxicity, but had no effect on fertility, can also be used
High-dose pilot study conducted limited tests.
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